Trial Outcomes & Findings for Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer (NCT NCT00601926)
NCT ID: NCT00601926
Last Updated: 2015-06-15
Results Overview
Progression was defined by using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
TERMINATED
PHASE2
5 participants
Up to 2 years
2015-06-15
Participant Flow
Participant milestones
| Measure |
Bevacizumab
15 mg/kg over 90 minutes
bevacizumab: 15 mg/kg over 90 minutes every 3 weeks
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab
n=5 Participants
15 mg/kg over 90 minutes
bevacizumab: 15 mg/kg over 90 minutes every 3 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsProgression was defined by using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Bevacizumab
n=5 Participants
15 mg/kg over 90 minutes
bevacizumab: 15 mg/kg over 90 minutes every 3 weeks
|
|---|---|
|
Progression Free Survival (PFS) When Bevacizumab is Administered to Patients With Unresectable and/or Metastatic Papillary Renal Cell Carcinoma.
|
12 months
Interval 3.0 to 25.0
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Includes patients with Complete response, partial response or stable disease
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.
Outcome measures
| Measure |
Bevacizumab
n=5 Participants
15 mg/kg over 90 minutes
bevacizumab: 15 mg/kg over 90 minutes every 3 weeks
|
|---|---|
|
Response Rate to Bevacizumab in This Population.
Complete Response
|
0 patients
|
|
Response Rate to Bevacizumab in This Population.
Progressive Disease
|
1 patients
|
|
Response Rate to Bevacizumab in This Population.
Partial Response
|
2 patients
|
|
Response Rate to Bevacizumab in This Population.
Stable Disease
|
2 patients
|
SECONDARY outcome
Timeframe: Up to 2 yearsGrade 3 or higher toxicities according to CTCAE version 3.0
Outcome measures
| Measure |
Bevacizumab
n=5 Participants
15 mg/kg over 90 minutes
bevacizumab: 15 mg/kg over 90 minutes every 3 weeks
|
|---|---|
|
Safety of Bevacizumab in This Population of Patients
|
15 toxicities
|
Adverse Events
Bevacizumab
Serious adverse events
| Measure |
Bevacizumab
n=5 participants at risk
15 mg/kg over 90 minutes
bevacizumab: 15 mg/kg over 90 minutes every 3 weeks
|
|---|---|
|
Cardiac disorders
Sudden Death
|
20.0%
1/5 • Number of events 5 • Adverse events were graded according to NCI CTCAE version 3.0
|
Other adverse events
| Measure |
Bevacizumab
n=5 participants at risk
15 mg/kg over 90 minutes
bevacizumab: 15 mg/kg over 90 minutes every 3 weeks
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5 • Number of events 2 • Adverse events were graded according to NCI CTCAE version 3.0
|
|
Investigations
Elevated Creatinine
|
20.0%
1/5 • Number of events 5 • Adverse events were graded according to NCI CTCAE version 3.0
|
|
Renal and urinary disorders
Proteinuria
|
80.0%
4/5 • Number of events 15 • Adverse events were graded according to NCI CTCAE version 3.0
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
5/5 • Number of events 21 • Adverse events were graded according to NCI CTCAE version 3.0
|
|
Vascular disorders
Hypertension
|
80.0%
4/5 • Number of events 17 • Adverse events were graded according to NCI CTCAE version 3.0
|
|
Investigations
Platelets
|
40.0%
2/5 • Number of events 6 • Adverse events were graded according to NCI CTCAE version 3.0
|
|
Nervous system disorders
Syncope
|
20.0%
1/5 • Number of events 1 • Adverse events were graded according to NCI CTCAE version 3.0
|
Additional Information
Paul Monk, MD
The Ohio State University Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place